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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceValiant Navion Thoracic Stent Graft System
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP100040
Supplement NumberS036
Date Received04/23/2018
Decision Date10/19/2018
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 18M-4033
Notice Date 10/25/2018
Advisory Committee Cardiovascular
Clinical Trials NCT02625324
NCT02652949
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the Valiant Navion Thoracic Stent Graft System, a modified device design from the Valiant Thoracic Stent Graft with Captivia Delivery System. This device is indicated for all lesions of the descending thoracic aorta (DTA) in patients having appropriate anatomy: 1) iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories;2) nonaneurysmal aortic diameter in the range of: 16 mm to 42 mm for fusiform and saccular aneurysms/penetrating ulcers, 16 mm to 44 mm for blunt traumatic aortic injuries, 19 mm to 45 mm for dissections; 3) proximal landing zone (nonaneurysmal aortic proximal neck length for fusiform and saccular aneurysms/penetrating ulcers or nondissected length of aorta proximal to the primary tear for blunt traumatic aortic injuries and dissections) of: >= 20mm for FreeFlo configuration and ?>=25mm for CoveredSeal configuration; and 4) nonaneurysmal aortic distal neck length >= 20mm for FreeFlo and CoveredSeal configurations for fusiform and saccular aneurysms/penetrating ulcers.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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